This course is an intensive two days pharmacovigilance training course with focus on GVP guidelines. The course will elaborate from current and draft GVP guidelines and system changes from the EMA implemented during 2018.

LEARNING OBJECTIVES

  • Expand your global safety knowledge
  • Apply legislation to ensure compliance
  • Submit compliant ADR data and avoid delays
  • Increase the accuracy of your causality assessment
  • Prepare for advanced crisis management control
  • Implement e-Submission strategies for ADR tracking & reporting

WHO SHOULD ATTEND

This course is valuable to professionals in drug safety with at least two years of experience, who wish to update their skills and enhance their knowledge by in- depth analysis of practical challenges and learn to implement solutions within ever changing pharmacovigilance environment:

  • Pharmacovigilance Professionals
  • Regulatory Affairs Specialists
  • Drug & Product Safety Associates
  • Medical Information Officers
  • Clinical Safety Specialists
  • Medical Affairs Specialists
  • Data Management Officer